MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MCOT PPM

Model Number	02-02045
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Chest Pain (1776)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported that the sensor was placed at their doctor's office ontop of her implanted defibrillator.Once they got home the patient started feeling pain on their chest, legs, stomach and started experiencing a headache.The patient removed the device instantly and was suggested to seek medical attention.The patient went to the emergency room (er) due to severe chest pains.The device is expected to be returned.
Additional Manufacturer Narrative
It was reported the patient experienced pain after the mcot c6 sensor was placed ontop of their defibrillator.The device was returned for investigation.Device was inspected for general physical integrity and found the blue seal on the sensor damaged from customer pry marks.Engineering evaluation could not replicate the reported event.The sensor is unlikely to have caused or contributed to the reported patient symptoms.Per the ifu, "the ecg recorder is not intended for use on patients with implanted pacemakers." a definitive root cause could not be determined.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: C6 MCOT PPM
• Common Device Name: C6 MCOT PPM
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121
• MDR Report Key: 17920944
• Report Number: 2133409-2023-00064
• Device Sequence Number: 6804381
• Product Code: DSI
• UDI-Device Identifier: B146EP2510
• UDI-Public: +B146EP2510
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K081444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 02-02045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 04/30/2024; 07/08/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 05/03/2024; 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female